BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1172083 · Received September 23, 2008

    Report

    Report Number
    2029203-2008-00632
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 24, 2008
    Report Date
    August 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORTION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WERE DISCARDED BY THE MEDICAL FACILITY, AND WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED WITH REPORTED SYMPTOMS OF FEVER AND CHILLS. THE PATIENT'S CULTURES CAME BACK POSITIVE FOR INFECTION AND SURGEON DECIDED TO EXPLANT THE PRECISION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORTION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ST LINEAR LEAD| ST LINEAR LEAD